SEREPAX

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

SEREPAX contains the active ingredient oxazepam. SEREPAX is used to treat anxiety, tremor, confusion or anxiety associated with alcohol withdrawal.

For more information, see Section 1. Why am I using SEREPAX? in the full CMI.

Do not use if you have ever had an allergic reaction to SEREPAX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use SEREPAX? in the full CMI.

Some medicines may interfere with SEREPAX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

• The dose will vary between patients. Your doctor will tell you how many tablets you need to take each day and when to take them.
• Swallow SEREPAX with a glass of water, with or without food.
• Take SEREPAX only for as long as your doctor recommends. It is usually used for short periods only (such as 2 to 4 weeks).

More instructions can be found in Section 4. How do I use SEREPAX? in the full CMI.

For more information, see Section 5. What should I know while using SEREPAX? in the full CMI.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SEREPAX. Some mild side effect include dizziness, drowsiness, feeling tired, lightheadedness or feeling faint and headache. Some serious side effects include confusion, behavioural or mood changes such as sudden outbursts of anger and increased excitement and hallucinations.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI

1 Name of Medicine

Oxazepam.

6.7 Physicochemical Properties

Oxazepam (Serepax), an antianxiety agent, is a 1,4 benzodiazepine with the chemical name 7-chloro-1,3- dihydro-3-hydroxy-5- phenyl-2H-1,4- benzodiazepine-2-one. Oxazepam is a creamy white to pale yellow powder that is practically odourless. It is almost insoluble in water and slightly soluble in alcohol and chloroform. It has a bitter taste. The molecular weight is 286.7.

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

Serepax tablets are available in two (2) strengths, 15 mg and 30 mg tablet. The excipients include lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Serepax oxazepam 15 mg tablets.

Serepax oxazepam 30 mg tablets.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Serepax is readily absorbed when given orally. Peak concentrations in plasma occur approximately 2-3 hours following administration of 30 mg. The half-life of oxazepam in human plasma ranges from 4 to 15 hours. At clinically relevant concentrations, oxazepam is 95% to 98% bound to plasma protein. Oxazepam is conjugated at its 3-hydroxy substituent to its glucuronide which accounts for at least 95% of the urinary excretion products. There are no active metabolites of oxazepam. Multiple dose therapy leads to no excessive drug accumulation.
There is no indication of induction of drug metabolising enzymes with oxazepam. Oxazepam is not a substrate for N-dealkylating enzymes of the cytochrome P450 system, nor is it hydroxylated to any significant extent.
The pharmacokinetics of oxazepam remain unaltered in older patients, however the elderly generally show increased central nervous system sensitivity to benzodiazepines, and may require a reduced dosage. Hepatic diseases (hepatitis, alcoholic cirrhosis) have a minimal influence on oxazepam kinetics, however these patients have increased cerebral sensitivity to benzodiazepines and dosage reduction may be advisable. As with other benzodiazepines, the pharmacokinetics of oxazepam may change in patients with impaired renal function, and the medication should be used with caution.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

Serepax is indicated for:
1. Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to Serepax therapy.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient.
2. Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

4.3 Contraindications

Serepax is contraindicated in:
1. Patients with known hypersensitivity to benzodiazepines.
2. Patients with chronic obstructive airways disease with incipient respiratory failure.
3. Patients with sleep apnoea.

4.4 Special Warnings and Precautions for Use

As with all patients taking CNS depressant medications, patients receiving Serepax should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Serepax therapy. Abilities may be impaired on the day following use. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of Serepax.
Following the prolonged use of Serepax at therapeutic doses, withdrawal from the medication should be gradual. An individualised withdrawal timetable needs to be planned for each patient in whom dependence is known or suspected. Periods from four weeks to four months have been suggested. As with other benzodiazepines, when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after use of Serepax (see Section 4.4 Special Warnings and Precautions for Use, Dependence).
In general, benzodiazepines should be prescribed for short periods only (e.g. 2-4 weeks). Continuous long-term use of Serepax is not recommended. There is evidence that tolerance develops to the sedative effects of benzodiazepines. After as little as one week of therapy, withdrawal symptoms can appear following the cessation of recommended doses (e.g. rebound insomnia following cessation of a hypnotic benzodiazepine).
Although hypotension has occurred only rarely, Serepax should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in elderly patients.
Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Serepax could increase the muscle weakness in myasthenia gravis and should be used with caution in this condition.
Caution should be used in the treatment of patients with acute narrow angle glaucoma (because of atropine-like side effects).

Blood dyscrasias.

Depression, psychosis and schizophrenia.

Paradoxical reactions.

Impaired respiratory function.

Epilepsy.

Abuse.

Dependence.

Use in hepatic impairment.

Use in renal impairment.

Use in elderly.

Paediatric use.

Effect on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. The benzodiazepines, including Serepax, produce additive CNS depressant effects when coadministered with other medications which themselves produce CNS depression, e.g. barbiturates, alcohol, sedatives, tricyclic antidepressants, nonselective MAO inhibitors, phenothiazines and other antipsychotics, skeletal muscle relaxants, antihistamines, or narcotic analgesics and anaesthetics.
2. The cytochrome P450 system has not been shown to be involved in the disposition of oxazepam and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with oxazepam.
3. The anticholinergic effects of other drugs, including atropine and similar drugs, antihistamines and antidepressants, may be potentiated.
4. Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together, and that serum level monitoring of the anticonvulsant be performed more frequently.
5. Minor EEG changes, usually low voltage fast activity, of no known clinical significance, have been reported with benzodiazepine administration.

4.6 Fertility, Pregnancy and Lactation

Impairment of fertility.

4.8 Adverse Effects (Undesirable Effects)

More common reactions.

Less common reactions.

Cardiovascular.

Dermatological.

Gastrointestinal.

General.

Haematological.

Musculoskeletal.

Nervous system.

Psychiatric.

Serious or life threatening reactions.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

Serepax is administered orally. For optimal results, dose, frequency of administration and duration of therapy should be individualised according to patient response.
For mild to moderate anxiety, with associated tension, irritability, agitation or related symptoms of functional origin or secondary to organic disease, the usual dose is 7.5 to 15 mg, 3 or 4 times daily.
For severe anxiety syndromes, agitation or anxiety associated with depression, the usual dose is 15 to 30 mg, 3 or 4 times daily.
For older patients with anxiety, tension, irritability and agitation, the initial dose is 7.5 mg, 2-3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily.
For alcoholics with tremulousness or anxiety on withdrawal, the usual dose is 15 to 30 mg, 3 or 4 times daily. Serepax should not be administered to alcoholics with acute inebriation.

Paediatric use.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS depressant medications, patients receiving Serepax should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Serepax therapy. Abilities may be impaired on the day following use. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of Serepax.

4.9 Overdose

Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, coma, and very rarely proves fatal.

Treatment.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Serepax 15 mg tablets contain the following excipients: magnesium stearate, microcrystalline cellulose, polacrilin potassium and lactose monohydrate.
Serepax 30 mg tablets contain the following excipients: magnesium stearate, methyl cellulose, polacrilin potassium and lactose monohydrate. Serepax 30 mg also contains Sunset Yellow as a coloring agent.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

PVC/Aluminium blister packs of 5*, 25 and 50's*.
Note: pack sizes marked with '*' are currently not available on the Australian market.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes